Nutriceutical gels

ABSTRACT

A nutriceutical food product includes a solid matrix and a liquid combined into a gel. The nutriceutical food product may include an immune modulator, such as transfer factor and/or a nanofraction immune modulator. A fruit component may be included in the nutriceutical food product. The fruit component may include at least one oligoproanthocyanidin-containing fruit, such as açai.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/436,062, filed on May 5, 2009, and titled NUTRICEUTICAL GELS, issuedas U.S. Pat. No. 9,028,882 on May 12, 2015, which is acontinuation-in-part of U.S. patent application Ser. No. 11/415,837,filed May 2, 2006, pending, which claims the benefit of priority under35 U.S.C. §119(e) to the filing date of U.S. Provisional PatentApplication Ser. No. 60/677,226, filed May 2, 2005, for TRANSFER FACTORPREPARATIONS AND ASSOCIATED METHODS. This application is also acontinuation-in-part of U.S. patent application Ser. No. 11/855,944,filed Sep. 14, 2007, pending, which claims the benefit of priority under35 U.S.C. §119(e) to the filing date of U.S. Provisional PatentApplication Ser. No. 60/848,348, filed Sep. 29, 2006, for IMMUNEMODULATORS, PREPARATIONS AND COMPOSITIONS INCLUDING IMMUNE MODULATORS,TESTS FOR EVALUATING THE ACTIVITY OF IMMUNE MODULATORS AND PREPARATIONSAND COMPOSITIONS INCLUDING THE SAME, AND METHODS. The entire disclosureof each of the foregoing applications is hereby incorporated byreference.

TECHNICAL FIELD

The present invention relates generally to natural supplements, ornutriceutical food products and, more specifically, to gel-basednutriceutical food products. The nutriceutical food products to whichthe present invention relates may include an immune modulator, such astransfer factor or a nanofraction immune modulator, which may bedistributed throughout a gel-based matrix. The present invention alsorelates to acai-based nutriceutical products.

SUMMARY

The present invention includes various embodiments of a nutriceuticalfood product in the form of a gel, or a semirigid colloidal dispersionof a solid matrix with a liquid. Some embodiments of a nutriceuticalfood product of the present invention include an immune modulator, whichmay be distributed throughout the solid matrix. The immune modulator maycomprise transfer factor and/or a nanofraction immune modulator of thetype described in U.S. patent application Ser. No. 11/855,944, filedSep. 14, 2007, the entire disclosure of which is, by this reference,incorporated herein. When distributed throughout the gel, the immunemodulator may retain substantially all of one or more of its activities(e.g., components of the liquid component may not interfere with one ormore activities of the immune modulator), or one or more of theactivities of the immune modulator may actually be enhanced by one ormore components of the gel component of the nutriceutical food product.

Various embodiments of nutriceutical food products of the presentinvention include a fruit component. The fruit component may include atleast one oligoproanthocyanidin (“OPC”)-containing fruit or an extractthereof. The term “extract” is broadly defined herein, including anyOPC-including part of a fruit. Examples of extracts include, withoutlimitation, juices (dilute, normal concentration, or concentrate),dehydrated fruit, and powders including one or more components of thefruit. In some embodiments of such a nutriceutical food product, atleast some of the fruit component is present in liquid form. In someembodiments, at least some of the fruit component may be included in thenutriceutical food product in solid form, where it may be incorporatedinto the gel matrix or merely reside within voids of the gel matrix,where it may be distributed throughout the gel matrix (e.g., as a fruitpectin).

Another aspect of the present invention includes a process for making anedible preparation that includes an immune modulator, such as transferfactor and/or a nanofraction immune modulator. The process includesmixing a fruit component with the immune modulator. Preservatives mayalso be included in the mixture. The mixture may be chilled to preventmicrobial growth. To further prevent microbial growth, the mixture maybe pasteurized before chilling. Alternatively, the mixture may besterilized.

Other features and advantages of the present invention will becomeapparent to those of ordinary skill in the art through consideration ofthe ensuing description and the appended claims.

DETAILED DESCRIPTION

In an exemplary embodiment of a gel-based nutriceutical food product,the gel comprises a solid polymeric matrix throughout which a liquid isdispersed.

The solid polymeric matrix may comprise a galactomannan, apolysaccharide (e.g., xanthan, a fruit pectin, etc.), gelatin, or anyother suitable gelling agent. In some embodiments, a plurality ofgelling agents are used to provide desired properties, such asviscosity, consistency, and edibility.

Various embodiments of nutriceutical food products that incorporateteachings of the present invention include a fruit component. The fruitcomponent includes at least one fruit that naturally includes OPC or ajuice or other extract of such a fruit. By way of nonlimiting example,the fruit component may include one or more of açai, elderberry, grape,and pomegranate or an extract thereof. OPC is a known antioxidant andmay, therefore, be useful in neutralizing or otherwise acting againstfree radicals and other oxidants, which may adversely affect cellmembranes, cause accelerated cellular aging, and are known or believedto be at least indirectly responsible for a wide variety of diseasestates, as well as compromised immunity, in living beings.

In embodiments of nutriceutical food products that include fruitcomponents, the fruit component may be in solid form, in liquid form, orin some combination of solid and liquid forms. When the fruit componentis included in solid form, it may be incorporated into the matrix (e.g.,as pectin, such as pectin of an OPC-containing fruit, etc.) or it may bedispersed throughout the matrix (e.g., as chunks, bits, etc.).

An immune modulator may be present within (e.g., dispersed throughout,dissolved in, etc.) the liquid component of various embodiments ofnutriceutical food products of the present invention. When mixed withthe liquid component, the immune modulator may retain substantially allof one or more of its activities (e.g., components of the liquidcomponent may not interfere with one or more activities of the immunemodulator), or one or more of the activities of the immune modulator mayactually be enhanced by one or more components of the liquid componentof the nutriceutical food product.

The immune modulator may include transfer factor. The transfer factormay include any type of transfer factor, as well as a combination of twoor more types of transfer factor. For example, avian transfer factor,bovine transfer factor, or any other type of transfer factor may beincluded in the transfer factor component. The transfer factor of thetransfer component factor may be derived from any suitable, acceptablesource. For example, avian transfer factor may be obtained from eggs,such as by a process disclosed in U.S. Pat. No. 6,468,534 to Hennen etal. (hereinafter “Hennen”), the disclosure of which is herebyincorporated herein, in its entirety, by this reference. An example ofthe manner in which bovine transfer factor may be obtained is disclosedin U.S. Pat. No. 4,816,563 to Wilson et al. (hereinafter “Wilson”), thedisclosure of which is hereby incorporated herein, in its entirety, bythis reference. Compositions that include two or more types of transferfactor, as well as processes for combining and processing two or moretypes of transfer factor, are disclosed in U.S. Pat. No. 6,866,868 toLisonbee et al. (hereinafter “Lisonbee”), the disclosure of which ishereby incorporated herein, it its entirety, by this reference.

Transfer factor is known or believed to improve the oxidative balance ofa living being, as well as to enhance the effectiveness of antioxidants,as demonstrated by the disclosure of the international patentapplication filed pursuant to the Patent Cooperation Treaty and havingInternational Publication Number WO 2004/041071 A2 (hereinafter“Dadali”), the disclosure of which is hereby incorporated herein, in itsentirety, by this reference.

As an alternative to transfer factor, the immune modulator of variousembodiments of a nutriceutical food product of the present invention maycomprise a nanofraction immune modulator of the type disclosed by U.S.patent application Ser. No. 11/855,944.

Other embodiments of nutriceutical food products of the presentinvention may include a plurality of different immune modulators, suchas combinations of transfer factor and nanofraction immune modulators.Various examples of compositions that include transfer factor andnanofraction immune modulators are also disclosed by U.S. patentapplication Ser. No. 11/855,944.

A nutriceutical food product of the present invention may also includeone or more preservatives. Suitable preservatives, such as thoseaccepted for use in foods and beverages, may be used. Any preservativesthat are included in a nutriceutical food product of the presentinvention may be able to withstand pasteurization processes. Examples ofpreservatives that may be included in an edible preparation of thepresent invention include, but are not limited to, sodium benzoate andpreservatives from the paraben family of chemicals.

A particular embodiment of gel-based nutriceutical food product thatincorporates teachings of the present invention is described in thefollowing example:

Example 1

TABLE 1 % of % of Total Total Density Juices Ingredient (w/w) (g/ml)(v/v) Water 75.490 1.000 RioVida Juice Blend 15.965 Apple Juice 1.346 19Purple Grape Juice 1.330 19 Blueberry Juice 1.315 18 Pomegranate JuiceElderberry Juice 1.315 15 Açai Powder 0.325 14 Transfer FactorTri-Factor Blend 1.880 Glycerine (Vegetable) 4.210 1.249 Grape colorconcentrate (e.g., 0.510 1.306 MEGANATURAL ™ purple from CanandaiguaConcentrates & Colors, a Division of Canandaigua Wine Company of Madera,California) Vitamin C 0.190 Flavorings 0.428 Berry flavor (BE-01407)1.000 Berry flavor (BE-01271) 1.000 Natural Vanilla (VA-01239) 1.000Monolaurin (glycerol monolaurate) 0.002 Gums (Xanthan and Guar Gum, at a1.000 ratio of 1:1 w/w)

Transfer Factor Tri-Factor Blend includes transfer factor (includingbovine transfer factor from cow colostrum and avian transfer factor fromthe yolk of a chicken's egg) and nanofraction immune modulators.

The flavorings listed in TABLE 1 are available from Flavors Inc.

Glycerol monolaurate is a surfactant. A surfactant may be useful formaintaining homogeneity (i.e., for keeping the components of thenutriceutical food product, including, but not limited to, any immunesupport component present in the nutriceutical food product, dispersedsubstantially homogeneously throughout the nutriceutical food product).

A daily dosage of about one fluid ounce (about 30 ml) or more (e.g.,about two fluid ounces, or 60 ml, etc.) of a composition withingredients in the proportions listed in TABLE 1 may be administered toor consumed by a subject. In addition to the numerous known and believedbenefits of antioxidants, including the benefits of OPC andOPC-containing fruits such as açai, administration or consumption of anutriceutical food product that incorporates teachings of the presentinvention provides the subject with the additional and sometimessynergistic beneficial effects of transfer factor, which are known inthe art, as evidenced by the disclosures of Dadali, Hennen, Lisonbee,and Wilson, and of nanofraction immune modulators.

An edible preparation may be made by mixing components of a food basewith transfer factor by processes that are known in the art. Suitableprocesses that may be used to manufacture edible preparations of avariety of different forms are well known and within the skill of thosein the relevant art. Known techniques, such as those disclosed in“Principles and Practices of Small- and Medium-Scale Fruit JuiceProcessing,” Food and Agricultural Organization of the United Nations(FAO) Services Bulletin 146 (Rome, 2001), the entire disclosure of whichis hereby incorporated herein by this reference, may be used in one ormore parts of a process for manufacturing various embodiments ofnutriceutical food products of the present invention.

Processes that are used to manufacture nutriceutical food productsaccording to the present invention may be effected at a low temperature(e.g., between about 0° C. and about 10° C., at about 4° C., etc.), suchas in a refrigerated environment, then transported and stored at suchtemperatures to reduce the likelihood of microbial growth orproliferation therein.

Alternatively, a nutriceutical food product that is in a form that isnot completely dry may be pasteurized or sterilized. Pasteurizationprocesses, which decrease the number of microorganisms present, but donot entirely eliminate the microorganisms, improve the stability ofproducts that are to be stored at reduced temperatures (e.g., frozen orrefrigerated, or “chilled”). When a nutriceutical food product issterilized, all or substantially all microorganisms therein are killedor inactivated, facilitating prolonged storage of the nutriceutical foodproduct at room temperature or even higher temperatures.

As an example, a nutriceutical food product that includes transferfactor and/or nanofraction immune modulators may be sterilized by knownsuperheated steam injection processes. The temperatures and durations ofsuch processes depend, of course, upon the form and ingredients of thecomposition to be sterilized. When making a liquid preparation, theresulting nutriceutical food product may be “flash” heated to aparticular temperature (e.g., 250° F.) for a corresponding duration(e.g., two seconds). Alternatively, a sterilization or pasteurizationprocess of different duration and temperature may be used, so long asthe duration and temperature of the process are in substantial accordwith a practice that has been accepted in the art, such as use of thefollowing equation:

t _(p)=5·10¹⁴ ·e ^(−0.4353·Tmo),

where t_(p) is the minimum duration of the process, and T_(mo) is thetemperature at which the process is effected.

Of course, processes that reduce microbial load on a nutriceutical foodproduct of the present invention need not comprise heat-treatmenttechniques. Sterilization or other microbial load-reducing techniquesthat employ other means (e.g., filtration, antimicrobial ingredients,etc.) may also be used in manufacturing a nutriceutical food product.Examples of suitable processes are disclosed in Hughes, D. E., andNyborg, W., “Minimally Processed Fruits and Vegetables: ReducingMicrobial Load by Nonthermal Physical Treatments,” Food Technology52(6): 66-71 (1997), the disclosure of which is hereby incorporatedherein, in its entirety, by this reference.

It is desirable that, following pasteurization or sterilization, thetransfer factor and/or nanofraction immune modulators retain some if notsubstantially all or all of their activity. A variety of pasteurizationor sterilization processes may be employed, including pasteurization orsterilization processes that may be used to reduce microbial counts orcompletely eliminate microorganisms from foods. As many sterilizationprocesses are known to significantly reduce the activity of certainproteins, including antibodies, a study was performed to determinewhether transfer factor retains at least some of its activity followingpasteurization.

In the study, mouse footpad assay techniques, similar to those disclosedin J. Natl. Cancer Inst. 55(5):1089-95 (November 1975), were used todetermine the affects of heat pasteurization or sterilization processes(specifically, superheated steam injection processes) on liquidnutriceutical food products including transfer factor. Two sterilizedsamples were compared with an unsterilized sample, as well as with anegative control and a positive control.

Separate populations of six mice were tested for each of the fivesamples and controls. The tests were conducted in two phases, a firstthat immediately followed heat sterilization of the samples, and asecond that was conducted after storing the two heat sterilized samplesat a temperature of about 40° C. for about three months, which iswell-accepted in the art to be the equivalent of about one year ofstorage at room temperature. Thirty different mice were used in eachphase of the study. The following procedures were followed in each phaseof the study.

In the positive control (i.e., the “fifth group”), fourteen days priorto testing, the footpads of the right rear feet of six BALB/c micehaving ages of about nine weeks to about ten weeks were anesthetizedwith isoflurane. Then 0.02 ml of an about 50/50 (wt/wt) mixture ofFreund's adjuvant and bovine rhinotracheitis virus diarrhea vaccine wasadministered intramuscularly to each mouse by way of two injections atthe base of each side of the mouse's tail. This early injection ofantigen allows the mice of the positive control group to elicit theirown primary immune response and secondary, or delayed-typehypersensitivity response to the antigen. The mice of the other fivegroups were not preexposed to the antigen in this manner.

About twenty-four hours before evaluating the hind footpads of the mice,the six BALB/c mice of each group, which were of similar age to the miceof the positive control group, were anesthetized with isoflurane. About0.5 ml of a sample solution or control solution was then administered bysubcutaneous injection at the back of the neck of each mouse.

In the first group (see EXAMPLE 2 below), which was the negative controlgroup, the back of the neck of each mouse was injected with about 0.5 mlof sterile saline solution.

In the second group (see EXAMPLE 3 below), the sample solution included16% solids (w/v) of a reconstituted (in distilled, deionized water)lyophilized colostrum fraction that included transfer factor. Thesolution was set at a pH of 4.0, which was intended to estimate the pHof a fruit juice preparation (the actual pH of which is about 3.6 orabout 3.7). Following reconstitution and pH adjustment, the solution wassterilized by heating the same to a temperature of 250° F. for about twoseconds.

In the third group (see EXAMPLE 4 below), the sample solution included16% solids (w/v) of a reconstituted (in distilled, deionized water)lyophilized colostrum fraction that included transfer factor. The pH ofthe resulting solution was not adjusted and, thus, was neutral (i.e.,7.0) or slightly basic (i.e., greater than 7.0)). Followingreconstitution, the solution was sterilized by heating the same to atemperature of 250° F. for about two seconds.

In the fourth group (see EXAMPLE 5 below), the sample solution was aconcentrate of a colostrum fraction that included transfer factor, whichhad been diluted to about 16% solids (w/v) in distilled, deionizedwater. This solution was not heat sterilized or pH adjusted.

The mice of the fifth group (see EXAMPLE 6 below), which was thepositive control groups, respectively, received sterile saline solution.

At the start of the mouse footpad assay, the right hind footpad and theleft hind footpad of each mouse were measured, such as with a Starrettgauge. The right hind footpad of each of the thirty mice during eachphase of the study was then subcutaneously injected with anantigen-containing solution. The footpad on the left hind foot of eachof the thirty mice in each phase, which was used as a control, wasinjected with about the same volume of a control solution, such as asterile saline diluent, as the volume of antigen-containing solutionthat was injected into right hind footpad.

After a sufficient amount of time (e.g., about twenty-four hours) forthe secondary immune response components of the immune system of eachmouse to respond, each mouse was again anesthetized and the distancesacross right and left hind footpads were again measured. A significantamount of swelling, determined by an increase in the distance across aright hind footpad of a mouse from the initial measurement to the secondmeasurement, is indicative of the occurrence of a delayed-typehypersensitivity reaction in that footpad.

The results of the mouse foot pad assays, and some accompanyinganalysis, are set forth in EXAMPLES 2 through 5 and 7:

Example 2

In the first phase of the study, the footpads on the right hind feet ofthe six mice of the negative control, or first group, exhibited, onaverage, about 6.35 micrometers more swelling about twenty-four hoursafter they were injected with the antigen solution than the swellingmeasured in the footpads of the left hind feet of these mice, which weremerely inoculated with sterile saline.

The results for the negative control group during the second phase ofthe study are set forth in the following table:

TABLE 2 Foot Pad Foot Pad Foot Pad (difference) Foot (untreated) (final)(microm- Mouse (left/right) (micrometers) (micrometers) eters) 1 Left(control) 1930.40 1955.80 25.40 Right (test) 1905.00 1930.40 25.40 2Left (control) 1981.20 2006.60 25.40 Right (test) 2006.60 2057.40 50.803 Left (control) 2057.40 2057.40 0.00 Right (test) 2032.00 2057.40 25.404 Left (control) 2006.60 2032.00 25.40 Right (test) 2032.00 2057.4025.40 5 Left (control) 1955.80 2006.60 50.80 Right (test) 1930.401955.80 25.40 6 Left (control) 1905.00 1930.40 25.40 Right (test)1876.60 1955.80 76.20Similar to the results from the first phase, the footpads of the righthind feet of the mice of the negative control group exhibited, onaverage, only 12.70 micrometers more swelling about twenty-four hoursafter antigen injection than the footpads of the left hind feet of thesame mice exhibited twenty-four hours after sterile saline injection. Astwenty-four hours is not a sufficient period of time for a mouse tomount a primary (i.e., antibody-mediated) immune response to theantigen, these insignificant differences in swelling show that the micedid not exhibit a significant secondary immune response to the antigen.

Example 3

In the first phase of the study, about twenty-four hours after they wereinjected with the antigen solution, the footpads on the right hind feetof the six mice of the second group of mice (which mice had previouslybeen inoculated with a solution including 16% solids (w/v) colostrum atpH=4.0) swelled, on average, by 50.80 micrometers more than the swellingthat was measured in the footpads of the left hind feet of these mice.These results indicate that there was a greater secondary, ordelayed-type hypersensitivity, immune response in the footpads intowhich antigen was injected than in the footpads into which no antigenwas injected, which were likely swollen merely because they were piercedby a needle.

In the second phase of the study, similar results were obtained, as setforth in the following table:

TABLE 3 Foot Pad Foot Pad Foot Pad (difference) Foot (untreated) (final)(microm- Mouse (left/right) (micrometers) (micrometers) eters) 1 Left(control) 1955.80 2006.60 50.80 Right (test) 1981.20 2057.40 76.20 2Left (control) 1930.40 2006.60 76.20 Right (test) 1955.80 2108.20 152.403 Left (control) 1955.80 2006.60 50.80 Right (test) 1981.20 2082.80101.60 4 Left (control) 2032.00 2057.40 25.40 Right (test) 2057.402108.20 50.80 5 Left (control) 1930.40 2006.60 76.20 Right (test)1955.80 2032.00 76.20 6 Left (control) 2057.40 2108.20 50.80 Right(test) 2032.00 2159.00 127.00More specifically, the footpads of the right hind feet of the six miceof the second group swelled so that they measured, on average, 42.33micrometers more than the swelling that was measured in the footpads ofthe left hind feet of these mice before and after inoculation of theirfoot pads with the antigen solution. The similar results between thefirst and second phases of the study indicate that, once a liquidsolution that includes transfer factor has been heat sterilized, thereis little or no change in the activity of the transfer factor afterprolonged storage of the solution.

Example 4

The results for the third group of mice (which mice had previously beeninoculated with a solution including 16% solids (w/v) colostrum atnormal pH) were similar to the results for the second group in the firstand second phases of the study.

In the first phase of the study, about twenty-four hours after thefootpad injections, the antigen solution-inoculated footpads on theright hind feet of the six mice of the third group of mice swelled, onaverage, by 35.98 micrometers more than the swelling that was measuredin the sterile saline-inoculated footpads of the left hind feet of thesemice. These results indicate that there was a greater secondary, ordelayed-type hypersensitivity, immune response in the footpads intowhich antigen was injected than in the footpads into which no antigenwas injected, which were likely swollen merely because they were piercedby a needle.

In the second phase of the study, similar results were obtained, as setforth in the following table:

TABLE 4 Foot Pad Foot Pad Foot Pad (difference) Foot (untreated) (final)(microm- Mouse (left/right) (micrometers) (micrometers) eters) 1 Left(control) 2006.60 2032.00 25.40 Right (test) 2032.00 2082.80 50.80 2Left (control) 2057.40 2057.40 0.00 Right (test) 2006.60 2108.20 101.603 Left (control) 1981.20 2006.60 25.40 Right (test) 2057.40 2082.8025.40 4 Left (control) 2006.60 2057.40 50.80 Right (test) 2032.002082.80 50.80 5 Left (control) 2057.40 2082.80 25.40 Right (test)2082.80 2159.00 76.20 6 Left (control) 2082.80 2108.20 25.40 Right(test) 2108.20 2159.00 50.80These results show that the footpads of the right hind feet of the sixmice of the third group swelled so that they measured, on average, 33.87micrometers more than the swelling that was measured in the footpads ofthe left hind feet of these mice before and after inoculation of thefoot pads with the antigen solution. The similar results between thefirst and second phases of the study indicate that, following prolongedstorage, there was little or no change in the activity of the transferfactor in a heat-sterilized solution.

Example 5

These results were confirmed by the results that were obtained from thefourth group of mice. In particular, during the first phase of thestudy, the footpads of the right hind feet of mice in the fourth group(which included mice that had been inoculated with a diluted liquidcolostrum fraction that was not heat sterilized) exhibited, on average,about 35.98 micrometers more swelling than the foot pads of left hindfeet of these mice about twenty-four hours after these footpads had beeninoculated with antigen solution and sterile saline, respectively.

Similar results were obtained during the second phase of the study, inwhich the average difference was 42.33 micrometers, as evidenced by thefollowing data:

TABLE 5 Foot Pad Foot Pad Foot Pad (difference) Foot (untreated) (final)(microm- Mouse (left/right) (micrometers) (micrometers) eters) 1 Left(control) 1955.80 2032.00 76.20 Right (test) 1981.20 2082.80 101.60 2Left (control) 2006.60 2057.40 50.80 Right (test) 2032.00 2108.20 76.203 Left (control) 1955.80 2006.60 50.80 Right (test) 1930.40 2057.40127.00 4 Left (control) 1955.80 2082.80 127.00 Right (test) 1905.002032.00 127.00 5 Left (control) 2032.00 2082.80 50.80 Right (test)2057.40 2184.40 127.00 6 Left (control) 1955.80 1955.80 0.00 Right(test) 2006.60 2057.40 50.80As these results are comparable to (i.e., not significantly greaterthan) those obtained with heat-sterilized solutions (see the resultsfrom EXAMPLES 3 and 4), it is apparent that heat sterilization of asolution that includes transfer factor does not significantly diminishor reduce the activity of the transfer factor.

Example 6

This conclusion was verified by data from another mouse footpad assay,in which six BALB/c mice were inoculated, behind the neck, with 0.5 mlof a solution including 16% solids (w/v) of a spray-dried colostrumfraction that had been reconstituted in distilled, deionized water.About twenty-four hours later, the mice were anesthetized withisoflurane, then footpads on their hind feet measured and inoculated inthe manner described above (i.e., left footpad with sterile saline,right footpad with the antigen solution). After about anothertwenty-four hours, the footpads were again measured. The right footpadsof these mice swelled, on average, about 42.33 micrometers more than thefootpads on the left hind feet of these mice. This value is comparableto (i.e., not significantly different from) the differences noted abovewith respect to the second, third, and fourth groups of mice in both thefirst and second phases of the study detailed in EXAMPLES 2 through 5and 7, further supporting the conclusion that heat sterilization of asolution that includes transfer factor, such as the solutions that weretested on the second and third groups of mice (EXAMPLES 3 and 4) doesnot have a significant adverse affect on the activity of the transferfactor.

Example 7

The fact that the transfer factor with which the mice were inoculatedwas responsible for the increased secondary immune response is supportedby the results from the fifth group, or positive control group, of miceduring the second phase of the study, as set forth in the followingtable:

TABLE 6 Foot Pad Foot Pad Foot Pad (difference) Foot (untreated) (final)(microm- Mouse (left/right) (micrometers) (micrometers) eters) 1 Left(control) 1981.20 2006.60 25.40 Right (test) 2006.60 2082.80 76.20 2Left (control) 1828.80 1854.20 25.40 Right (test) 1879.60 2082.80 203.203 Left (control) 1905.00 1930.40 25.40 Right (test) 1981.20 2082.80101.60 4 Left (control) 2006.60 2057.40 50.80 Right (test) 2032.002184.40 152.40 5 Left (control) 2032.00 2057.40 25.40 Right (test)2057.40 2184.40 127.00 6 Left (control) 2108.20 2108.20 0.00 Right(test) 2082.80 2184.40 101.60These results, which show on average, 101.60 micrometers more swellingin the footpads that were inoculated with antigen solution over thosethat were inoculated with sterile saline, are similar to the 124.88micrometer difference seen in the mice of the positive control groupduring the first phase of the mouse footpad study. The greater swellingin the antigen solution-inoculated footpads of the mice of the positivecontrol group is indicative of a greater secondary immune response thanthat induced artificially by administration of transfer factor, as themice of the positive control group had a sufficient period of time(i.e., two weeks) to generate their own transfer factor and, thus, tomount their own secondary immune response to the antigen.

Once a nutriceutical food product of the present invention has beenmanufactured, it may be introduced into a clean or sterile container forsubsequent transport and storage.

Example 8

In another study, mouse footpad assays were conducted to determine theeffectiveness of transfer factor in heat-treated samples of a liquidsolution that included transfer factor that had been stored for oneyear. In total, four samples were prepared, two each having a pH ofabout 4 and two each having a pH of about 7. All of the samples had beenflash sterilized at a temperature of about 250° F. for about two secondsto about four seconds. The samples were subsequently stored for oneyear, with one each of the pH=4 and pH=7 samples having been stored atroom temperature (which varied from about 65° F. to about 74° F.) andone each of the pH=4 and pH=7 samples having been refrigerated (attemperatures of about 40° F.). After one year, the samples werelyophilized. Prior to testing, the lyophilized samples werereconstituted to desired concentrations, then administered in the mannerdescribed above.

In a first sample, which included liquid having a pH of about 4 that wasstored at room temperature, footpad swelling was, on average, 50.80micrometers greater in footpads that had been injected with antigenversus footpads that had merely been injected with saline. These resultswere repeated in second (liquid of a pH of about 7 that was stored atroom temperature), third (liquid of a pH of about 4 that wasrefrigerated), and fourth (liquid of a pH of about 7 that wasrefrigerated) samples, in which hind footpads that had been injectedwith antigen were, on average, respectively swollen 59.27, 67.73, and63.50 micrometers more than hind footpads that were merely injected withsaline.

Additionally, positive and negative controls were prepared as discussedabove. In the positive control, the average difference in swellingbetween antigen-injected footpads and saline-injected footpads was114.30 micrometers. In the negative control, the average difference inswelling between antigen-injected footpads and saline-injected footpadswas only 38.10 micrometers.

Taken together, these data indicate that the increased swelling was dueto the presence of transfer factor in the mice in the areas (hindfootpads) into which antigen was introduced. Additionally, these dataindicate that the transfer factor lost little or none of itseffectiveness after heat-treatment and prolonged storage. The activityof transfer factor in refrigerated samples appears to have been slightlyhigher than the activity of transfer factor in the room temperaturesamples.

Further, it appears from the foregoing that the pH at which the transferfactor is maintained (about 4 or about 7) has little or no effect on itslong term viability.

Although the foregoing description contains many specifics, these shouldnot be construed as limiting the scope of the present invention, butmerely as providing illustrations of some of the presently preferredembodiments. Similarly, other embodiments of the invention may bedevised which do not depart from the spirit or scope of the presentinvention. Features from different embodiments may be employed incombination. The scope of the invention is, therefore, indicated andlimited only by the appended claims and their legal equivalents, ratherthan by the foregoing description. All additions, deletions andmodifications to the invention as disclosed herein which fall within themeaning and scope of the claims are to be embraced thereby.

What is claimed:
 1. A composition, comprising: a gel, an oligomericproanthocyanidin and a transfer factor, wherein the oligomericproanthocyanidin is dispersed throughout the gel, the transfer factor isdispersed throughout the oligomeric proanthocyanidin and the oligomericproanthocyanidin is from acai.
 2. The composition of claim 1, whereinthe gel comprises xanthan and guar gum.
 3. The composition of claim 1,wherein the gel comprises xanthan, guar gum and pectin.
 4. Thecomposition of claim 3, wherein the pectin comprises fruit pectin. 5.The composition of claim 1, wherein the composition further comprises atleast one of an additional oligomeric proanthocyanidin-containing fruitjuice or an oligomeric proanthocyanidin-containing fruit extract.
 6. Thecomposition of claim 5, wherein the additional oligomericproanthocyanidin-containing fruit juice or the oligomericproanthocyanidin-containing fruit extract is derived from at least oneof elderberry, grape or pomegranate.
 7. The composition of claim 1,further comprising a surfactant.
 8. The composition of claim 7, whereinthe surfactant comprises glycerol monolaurate.
 9. The composition ofclaim 1, further comprising a preservative.
 10. The composition of claim9, wherein the preservative is selected from the group consisting ofsodium benzoate and paraben.
 11. The composition of claim 1, wherein thetransfer factor includes avian transfer factor and/or bovine transferfactor.
 12. The composition of claim 11, wherein the transfer factorcomprises avian transfer factor obtained from avian egg.
 13. Thecomposition of claim 1, wherein the composition is sterile.
 14. Thecomposition of claim 1, wherein the gel comprises a gelling agent. 15.The composition of claim 1, wherein the gel comprises gelatin.
 16. Afood product comprising: a gel, an oligomeric proanthocyanidin and atransfer factor, wherein the oligomeric proanthocyanidin is dispersedthroughout the gel, the transfer factor is dispersed throughout theoligomeric proanthocyanidin and the oligomeric proanthocyanidin is fromacai.
 17. A food product comprising: a gel, an oligomericproanthocyanidin and a transfer factor, wherein the oligomericproanthocyanidin is dispersed throughout the gel, the transfer factor isdispersed throughout the oligomeric proanthocyanidin.